Friday, January 14, 2011

On Monday, the Food and Drug Administration (FDA) formally announced new policies intended to increase transparency and public disclosure for its advisory committees. Although a number of new policies were announced, the one creating the most buzz is the policy barring an advisor from participating in a meeting if the FDA determines that he or she has a financial interest of more than $50,000. If the financial interest is less than $50,000, a waiver may be granted, but only if FDA officials "determine that there is an essential need for the advisor's particular expertise."

According to the FDA's press release, a financial interest would include "grants, stock holdings and contracts with a company that would be affected by the committee's recommendations." A more detailed description can be found in the final guidance document.

The new policies are almost surely a result of the increased scrutiny of FDA advisory committees by the public and Congress. The public outcry has been fueled by recent scandals in which members of FDA advisory committees vote to recommend drugs that they have a financial interest in, even when those drugs are likely to be harmful.

According to the Washington Post, "advisory committees play a central role in regulating drugs, medical devices and diagnostic tests. Their decisions largely determine what drugs and medical products can be marketed to Americans--because the agency nearly always follows the panels' guidance." If the advisory committees are as influential as the Post claims they are, the new policies may go a long way towards alleviating some of the influence that industry has on the FDA approval process. But I'm not overly optimistic.

A 2006 report on FDA advisory committees by the National Research Center for Women & Families analyzed "the voting patterns and committee discussions of a random sample of 6 of 16 drug advisory committees and 5 of 18 medical device advisory panels" between 1998 and 2005. The findings of the report seem to corroborate the tight link between advisory recommendations and FDA approval decisions. Within the report's sample, all of the drugs and 94% of the devices recommended by advisory committees were subsequently approved by the FDA.

However, the report's findings also suggest that the influence of advisory committees may be overstated. 45% of drugs and 43% of devices that were not recommended by the advisory committees were approved by the FDA anyway. If the advisory committees are susceptible to industry influence and the FDA is approving drugs and devices that even the "corrupt" advisory committees won't recommend, what does that say about the FDA?

This is not to say that advisory committees do not have a strong influence on the FDA approval process. The new financial conflict of interest disclosure policies are certainly a step in the right direction. But while it's easy to use the committee advisors as scapegoats, they are but one piece of an agency that is overly dependent on and sympathetic to the industry it is supposed to regulate.

Founded in 1981, the Project On Government Oversight (POGO) is a nonpartisan independent watchdog that champions good government reforms. POGO's investigations into corruption, misconduct, and conflicts of interest achieve a more effective, accountable, open, and ethical federal government.